NCT00164281已完成4 期
A Randomized, Placebo-Controlled Study of Limited vs. Continuous Isoniazid Tuberculosis Preventive Therapy in HIV-infected Persons in Botswana
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,995
- 试验地点
- 2
- 主要终点
- Incident tuberculosis
研究概览
简要总结
This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.
详细描述
Randomized, double blinded, two-arm comparative trial of continuous vs. limited isoniazid preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected
- •Age >=18 years
- •Tuberculin skin test positive or negative
- •Laboratory:
- •Hemoglobin (Hgb) >6.5 gm/dl;
- •Neutrophil count >1,000 cells/mm3;
- •Platelets >75,000/mm3;
- •AST (SGOT) <122 U/L;
- •Creatinine <1.5 mg/dl;
- •Beta HCG = negative
- •Karnofsky performance status >=60
- •Signed informed consent
排除标准
- •History of TB in the last 3 years or current active TB
- •History of noncompliance to chronic therapies
结局指标
主要结局
Incident tuberculosis
时间窗: During enrolment
次要结局
- Death(During enrolment)
- Adverse events(During provision of study medication)
研究者
研究点 (2)
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